Pilot Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.
研究概览
简要总结
This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.
详细描述
After randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure considerations may require removal of additional tissue for non-oncologic purposes. As per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven T2 malignant melanoma.
- •Eastern Cooperative Oncology Group (ECOG) score of 0-2.
排除标准
- •Visible additional disease that suggests a greater than T2 malignant melanoma
- •Unable to tolerate general anesthesia
- •Evidence of distant metastatic disease
- •Melanoma located on face or digits
结局指标
主要结局
Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.
时间窗: 2 years
Number of patients who agree to participate
次要结局
- Quality of life following surgery(One month post-surgery)
- Recurrence (disease free survival)(Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years)